DCH Cooling Pain Relief Spray, 10.5% Menthol

DCH COOLING PAIN RELIEF- menthol 10.5% spray
Derma Care Research Labs, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol 10.5%

Topical Analgesic

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, sprains, and cramps.

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

If swallowed, get medical help or contact a Poison Control Center right away.

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water.

Label

DCH COOLING PAIN RELIEF
menthol 10.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72839-639
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
JUNIPER BERRY (UNII: O84B5194RL)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72839-639-03	85 g in 1 CAN; Type 0: Not a Combination Product	05/24/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/24/2021

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Name	Address	ID/FEI	Business Operations
Establishment
Derma Care Research Labs, LLC		116817470	manufacture(72839-639)